Shanghai Junshi Biosciences announced that the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (TGA) has accepted the New Chemical Entity (NCE) application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of NPC. This NCE application was submitted through Project Orbis, an initiative of the FDA's Oncology Center of Excellence (OCE) that provides a collaborative mechanism and framework among the FDA and regulatory partners in other countries and regions, for concurrent submission and review of oncology drugs.

At present, seven other regulatory agencies have joined Project Orbis, including the TGA, Singapore Health Sciences Authority (HSA), Health Canada (HC), MHRA, etc. Project Orbis currently accepts applications for oncology indications. An application should generally qualify for FDA priority review, meaning that the drug must be intended to treat a serious disease and, if approved, would significantly improve the safety or efficacy of the treatment; furthermore, the drug should have a high impact and significant clinical benefits.

This NCE application is supported by results from JUPITER-02, a randomized, double-blind, placebo-controlled, multinational multi-center Phase III clinical study (NCT03581786), for the first-line treatmentof NPC and the results from POLARIS-02, a multi-center, open-label, pivotal Phase II clinical study (NCT02915432), for second-line or more prior treatments for recurrent or metastatic NPC. The results of JUPITer-02, the first multinational multi-center, double-blind, randomized, placebo- controlled Phase III clinical study with immuno-oncology therapy for the treatment of NPC with the largest sample size, were published at the plenary session of the 2021 American Society of Clinical Oncology (ASCO) annual meeting (#LBA2), and in Nature Medicine and the Journal of the American Medical Association (JAMA). The POLARIS-02 results were published online in January 2021 in the Journal of Clinical Oncology.

The results showed that toripalimab demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a median duration of response (DoR) of 12.8 months, and a median OS of 17.4 months with a manageable safety profile. So far, toripalimab has been approved for 6 indications in China, with 4 supplementary new drug applications (sNDA) currently under regulatory review. Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function).

Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, breast, liver, kidney, and skin. In the United States, the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for toripalimab in addition with cisplatin and gemclonal antibody for the treatment of adults with metastatic and recurrent locally advanced NPC, and for toripalimab.